MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION HURRICANE RX; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00545890
Medical Device Problem Codes	Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2019 as no event date was reported.The complainant was unable to report the device lot number; therefore the manufacture date and expiration date are unknown.According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
Note: this report pertains to one of two hurricane rx dilatation balloons and a spyscope digital access and delivery catheter used in the same patient and procedure.It was reported to boston scientific corporation that a spyscope digital access and delivery catheter and two hurricane rx dilatation balloons were used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.According to the complainant, during the procedure, the working channel sleeve protruded.Reportedly, no accessory device was inside the spyscope ds when the working channel sleeve protruded.A hurricane rx dilatation balloon was also used and the balloon part broke off.The same issue occurred with the second hurricane balloon.The procedure was completed with another hurricane rx dilatation balloon and a second spyscope digital access and delivery catheter.There were no patient complications reported as a result of this event.
Event or Problem Description
Note: this report pertains to one of two hurricane rx dilatation balloons and a spyscope digital access and delivery catheter used in the same patient and procedure.It was reported to boston scientific corporation that a spyscope digital access and delivery catheter and two hurricane rx dilatation balloons were used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.According to the complainant, during the procedure, the working channel sleeve protruded.Reportedly, no accessory device was inside the spyscope ds when the working channel sleeve protruded.A hurricane rx dilatation balloon was also used and the balloon part broke off.The same issue occurred with the second hurricane balloon.The procedure was completed with another hurricane rx dilatation balloon and a second spyscope digital access and delivery catheter.There were no patient complications reported as a result of this event.Correction: a hurricane rx dilatation balloon was also used and the balloon burst.The same issue occurred with the second hurricane balloon.
Additional Manufacturer Narrative
Block h11: correction block b5, h6 and h10 block b3: date of event: date of event was approximated to (b)(6) 2019 as no event date was reported.Block d4, h4: the complainant was unable to report the device lot number; therefore the manufacture date and expiration date are unknown.Block h6: problem code 1074 captures the reportable event of balloon burst.Block h10: according to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

• Brand Name: HURRICANE RX
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8407768
• Report Number: 3005099803-2019-01077
• Device Sequence Number: 2029973
• Product Code: FGE
• UDI-Device Identifier: 08714729283805
• UDI-Public: 08714729283805
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K001338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00545890
• Device Catalogue Number: 4589
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 03/11/2019
• Supplement Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1